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ACTIVE NOT RECRUITING
NCT04300855
PHASE2

Clinical Trial of Green Tea Catechins in Men on Active Surveillance

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin, (Sunphenon® 90D) containing 405 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance

Official title: Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2020-08-21

Completion Date

2027-02-27

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Sunphenon

The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months

DRUG

Placebo

Matching placebo

Locations (2)

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas Cancer Center

Westwood, Kansas, United States